ID
41693
Beschreibung
The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the Follow-Up Visit.
Stichworte
Versionen (1)
- 18.12.20 18.12.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
18. Dezember 2020
DOI
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Lizenz
Creative Commons BY-NC 4.0
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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122
Study Conclusion and Pregnancy Information
- StudyEvent: ODM
Beschreibung
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Beschreibung
date and time of subject completion or withdrawal
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C2348577
- UMLS CUI [2,2]
- C0040223
- UMLS CUI [3,1]
- C1710677
- UMLS CUI [3,2]
- C0011008
- UMLS CUI [4,1]
- C1710677
- UMLS CUI [4,2]
- C0040223
Beschreibung
subject withdrawn from study
Datentyp
text
Alias
- UMLS CUI [1]
- C0422727
Beschreibung
subject withdrawn from study; primary reason
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1549995
Beschreibung
other reason for withdrawal, specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1549995
- UMLS CUI [1,3]
- C2348235
Beschreibung
Data owner should check the box when data cleaning is complete
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1519316
Beschreibung
office use 1
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0442603
- UMLS CUI [1,2]
- C1524063
Beschreibung
office use 2
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0442603
- UMLS CUI [1,2]
- C1524063
Beschreibung
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschreibung
if yes, complete the paper Pregnancy Notification form
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3828490
Beschreibung
If Yes, complete the paper Pregnancy Notification form
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3828490
- UMLS CUI [1,2]
- C0919624
Ähnliche Modelle
Study Conclusion and Pregnancy Information
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C2348577 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C1710677 (UMLS CUI [3,1])
C0011008 (UMLS CUI [3,2])
C1710677 (UMLS CUI [4,1])
C0040223 (UMLS CUI [4,2])
C1549995 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1519316 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,2])
C0919624 (UMLS CUI [1,2])